Module 3 - Strategic case studies in practice

Further Studies

 ER layer coating weight gain and Polymer-2 viscosity have strong interaction.  Both factors are critical!  Control strategy: – Using fixed amount of Polymer- 1 and Polymer-2 – Tighten the Polymer-2 viscosity to the studied ranges instead of compendial limits

B:Viscosity

Disso @ 4h

A: ER layer coating weight gain

Don’t use insufficiently powered studies to force a favorable conclusion of non-criticality. The narrow range of ‘non-critical process parameter’ is still potentially critical.

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